1. Field of the Invention
The present invention relates to a system and method for treating hemorrhoids in a patient using a minimally invasive method. In particular it provides a method and a system for treating hemorrhoidal cushions by using laser technology.
2. Information Disclosure Statement
Hemorrhoids are dilated or bulging veins of the rectum and anus, caused by increased pressure in the rectal veins, resulting in bleeding, itching and pain. Pressure caused on the walls of the rectum weakens the muscles that support the hemorrhoidal vessels. These vessels then become enlarged and lose their support forming a sac-like protrusion inside the rectal canal, referred to as internal hemorrhoids or under the skin around the anus, called external hemorrhoids. When internal hemorrhoids push out of the anal opening, it is referred to as prolapsed hemorrhoids. Sometimes, blood clotting or thrombus is seen in external hemorrhoids; this condition is called a thrombosed external hemorrhoid. Hemorrhoids can occur at any time in all age groups and in both sexes. They are most common among adults ages 45 to 65. Hemorrhoids are also common in pregnant women.
The arteries supplying blood to the anal canal descend into the canal from the rectum above and form a rich network of arteries that communicate with each other around the anal canal. Because of this rich network of arteries, hemorrhoidal blood vessels have a ready supply of arterial blood. The blood vessels that supply the hemorrhoidal vessels pass through the supporting tissue of the hemorrhoidal cushions. The anal veins drain blood away from the anal canal and the hemorrhoids. These veins drain in two directions. The first direction is upwards into the rectum, and the second is downwards beneath the skin surrounding the anus. The suggestion based on earlier theories for hemorrhoid aetiology is that a local increase in venous pressure causes dilation of the hemorrhoid plexus within the anal cushions. This theory is refuted now based on recent studies of the vascular anatomy of the anal cushion.
Most common symptoms of hemorrhoids are bleeding and prolapse at defecation. Thrombosis and anal fissure cause pain. Other symptoms include soiling, itching or perianal irritations.
For moderate hemorrhoid conditions, there are numerous existing treatments, whose main objectives are to alleviate symptoms or to help avoid aggravation of the hemorrhoid condition. For instance, ointments, special diets, patches and hemorrhoid massage, which is used to stimulate blood flow in the treatment area.
A conventional treatment method is anal dilation, wherein the anal sphincter muscle is stretched or dilated to prevent hemorrhoids from increasing rectal pressure, as well as reduce the straining while passing stool. Potential side effects of this procedure are fecal incontinence or anal leakage. Furthermore, this method cannot be used in the older age group with weak sphincter muscles.
In rubber-hand ligation methods, a special rubber band is tied around internal mucosa above the dentate line. The band lifts the hemorrhoids below and cuts off blood circulation to the hemorrhoid. Within a week, the necrotic tissue will shrivel and fall off along with the band. In the case of multiple hemorrhoids, each is treated separately about one month apart. Common side effects of these methods include complications such as clotting of external hemorrhoids and bleeding.
In Doppler-guided ligation methods, a specially adapted proctoscope with an incorporated Doppler probe is used to ligate hemorrhoid arteries. The Doppler probe is inserted and used to locate the hemorrhoid arteries by audible alteration of signal. Once located, a needle holder is inserted into the lumen of the proctoscope and the artery is ligated with an absorbable suture into the submucosa. The procedure is repeated. Doppler-guided ligation of the hemorrhoid artery disrupts the arterial inflow and tethers the mucosa, causing the hemorrhoidal mass to shrink and retract. Currently this procedure is carried out under general anesthesia and few patients are able to tolerate it under simple sedation.
Sclerotherapy or injection therapy involves injecting a sclerosing or hardening agent into the base of the internal hemorrhoids. The sclerosing agent causes the vein walls to collapse and the hemorrhoids to shrivel up. This method can be used for treating multiple hemorrhoids at once and is more often used for treating older men and women with fragile veins. Sometimes abscesses are reported in patients.
Cryosurgery or freezing methods use liquid nitrogen or nitrous oxide to cool the cryoprobe to freezing temperatures. The frozen tip of the probe is then applied to the hemorrhoid to freeze and destroy the tissue. Two or three weeks later, the hemorrhoids will shrink and fall off. Both internal and external hemorrhoids can be treated by this method. This method is very painful and other complications include foul odor from discharge of treated hemorrhoids lasting for about a week, requiring use of absorbent pads. The open wound can also become infected.
Hemorrhoidectomy is a surgical method of removing hemorrhoids, usually done in severe cases. It is recommended for prolapsed or thrombosed internal hemorrhoids, or large and painful external ones. In this method, hemorrhoids are cut off using scalpels or a laser, the cut sewn up with stitches, and a small pad placed in the anus to absorb discharge from the region. This method requires anesthesia and hospitalization for a few days and patient must stay on sick leave for up to several weeks. This is therefore a very expensive method. Side effects can include severe pain, bleeding, narrowing of anal canal which may lead to anal fisures, inability to defecate and scarring.
Electric treatments of hemorrhoids apply an electric current directly into the deficient vein. Electric current, either negative or positive, causes a chemical or thermal reaction within the tissue that either destroys and/or obliterates the hemorrhoid. Examples of these treatments include bipolar electrotherapy and hemorrhoidolysis, in which therapeutic galvanic waves are applied directly to the hemorrhoid, producing a chemical reaction that shrinks and dissolves hemorrhoidal tissue. These treatments are limited to only internal hemorrhoids. Furthermore, they are time-consuming treatments, tedious for physician and patient, and may lead to anorectal fistula development.
Another method using laser energy for treating hemorrhoids has been proposed by Salfi et al. in U.S. Patent Publication 2008/0281204, which presents a system and method for treating branches of the superior hemorrhoidal artery by photocoagulation using laser energy. The treatment system photocoagulates the branches of superior hemorrhoidal artery in the anal and rectal regions using laser energy while causing minimal pain or discomfort to the patient. The post operative recovery is faster than alternative approaches with no complications. Anesthesia is no longer required, as it is in most other successful methods, greatly reducing complications and simplifying the treatment. This method can be successfully used in grade one and two hemorrhoids. Nevertheless, grade three hemorrhoids treatment may not be feasible with this technique by itself. Furthermore, shrinkage and retraction usually occurs some days after surgery, thus symptom relief can be delayed.
Plapler (See Photomedicine and Laser Surgery Volume 26, Number 2, 2008, Pp. 143-14 A New Method for Hemorrhoid Surgery: Experimental Model of Diode Laser Application in Monkeys) has published an experimental method of endovascular laser therapy for treating hemorrhoids using diode laser application to monkeys in which hemorrhoids were induced by ligation of the inferior hemorrhoidal vein. Laser energy was delivered to the surrounding submucosal interstitial tissue, reducing the hemorrhoids. A recent new method which consists in attacking the cushions in humans directly by submucosal delivery of laser energy is exposed by Karahaliloglu (See: Coloproctology 29, 2007, Nr. 6© Urban & Vogel. First Results after Laser Obliteration of First- and Second. Degree Hemorrhoids). Laser energy provides submucous obliteration with subsequent fibrotic tissue change of the hemorrhoidal vascular convolute. Performed without anesthesia, treatment leads to unpleasant pain sensations, so it is routinely carried out with application of 1 ml local anesthetic per knot, whereby all patients are pain free during treatment. This method has had high patient acceptance and satisfaction when performed properly. However, procedure is sometimes difficult to carryout due to bleeding of treated piles. Furthermore, although results are satisfactory regarding relief in a short period of time by direct shrinking of the hemorrhoidal cushion, this method does not attack the main cause of hemorrhoid formation. Additionally it may not be suitable for larger hemorrhoidal piles and therefore recurrence is probable over time.
Hence there remains a need for developing a suitable device and method for treating hemorrhoids using minimal invasive methods which can overcome or minimize the drawbacks reported in the above treatment methods. This should be achieved by reducing the dimensions of the hemorrhoidal cushion(s) preserving their function of fine continence, and to completely spare the sensible anodermal skin and the mucosa to reduce pain and wound circumference and to reduce patient inactivity time periods. Present invention addresses these needs.